Research Benefits for Hypothetical HIV Vaccine Trials: The Views of Ugandans in the Rakai

Abstract

Collaborative, multinational clinical research is complicated by thorny ethical issues, especially when sponsored by developed world entities and conducted in the developing world. An overarching ethical concern in all research is the possible exploitation of vulnerable individuals or populations. Exploitation, often understood as an unfair distribution of benefits,' may be more of a challenge in international research because of background disparities in health, health resources, and power between developed and developing countries.- Codes and guidelines have recommended pro- vision of benefits to participants or the host community as one means of minimizing exploitation in inter- national research.3 Ensuing debates on the type and level of benefit that should be provided have focused on issues such as compensation to individual research participants and post trial access to products proven effective.4 Although research participants are often reimbursed or compensated with money or other goods, researchers and members of research ethics boards sometimes disagree about what kind of reimbursement or compensation-and how much-is appropriate. International guidelines note that participants may be reimbursed or compensated for time, travel, and inconvenience with money or free medical care in acceptable amounts approved by local research ethics boards, as long as amounts are "not so large or the medical services so extensive as to induce prospective subjects to consent to participate in the research against their better judgment."6 Previous studies have shown that financial incentives may impact individuals' willingness to participate in HIV vaccine trials, but few studies have directly assessed respondents' opinions about whether research participants should be financially compensated.